Certification ISO

Conformance to ISO 9000 by U.S. companies was led by the chemical industry as a result of the importance of international trade to chemical companies. An ISO 9000 certification was once thought to be necessary for access to the European market (52). At the beginning of 1994, almost 20% of U.S. certifications went to chemical companies. The emphasis on registration continues at a fast pace, as certification is considered an important suppher selection criterion by U.S. chemical companies. 

The advent of ISO 9000 certification has helped bring the quality issue to a focus. While ISO 9000 emphasis is on documentation of methodology and performance to the documented methods, the discipline that results is a direct step toward improvements in reliability. Out of this seems to come a goal of continuous improvement. This is a sharp contrast to the high growth era that took place in the early 1980s when poor quality on the part of the equipment suppliers was a significant factor in the lack of reliability at the field operation level. 

ISO 9000 is not a statutory requirement and neither is certification, hence certification is voluntary. However, suppliers may be under pressure to obtain registration to ISO 9001, ISO 9002, or ISO 9003 in order to tender for contracts. Within the ISO 9000 certification scheme, the certification industry is regulated by accreditation bodies. An International Accreditation Forum (lAF) attempts to harmonize accreditation practices world-wide through ISO Guide 61. The accreditation bodies authorize certification bodies to conduct certification to prescribed standards - a process that is called accreditation. The accreditation body performs witness audits and desk audits of the certification body to ensure compliance with the conditions of accreditation. 

The certification business has grown enormously in the last ten years. The International Accreditation Forum (lAF) recorded 616 accredited certification bodies in January 1999. The experience of the vehicle manufacturers with ISO 9000 certification led them to question the wisdom of so many certification bodies chasing the same business in a competitive market. The results seemed to indicate that cost reductions by the certification bodies led to a decline in the quality of auditing and that was the opposite of what the vehicle manufacturers wanted. The vehicle manufacturers had not seen a significant rise in product quality as a result of ISO 9000 and they believed this was partially due to the quality of the accreditation and certification schemes being operated as well as inadequacies in the quality system standard. When the four national automotive schemes were launched, great emphasis was placed on regulating more closely the accreditation and certification schemes. From a customer perspective, the ISO 10011 scheme had some particular problems ... 

You need to develop documented procedures that define your subcontractor evaluation and selection process and in certain cases this may result in several closely-related procedures for use when certain conditions apply. Do not try to force every purchase through the same selection process. Having purchasing policies that require three quotations for every purchase regardless of past performance of the current subcontractor is placing price before quality. Provide flexibility so that the policies and procedures complexity match the risks anticipated. Going out to tender for a few standard nuts and bolts would seem unwise. Likewise, placing an order for lm of equipment based solely on the results of a third party ISO 9000 certification would also seem unwise. 

Class B Demonstrated capabilify. This is the class of those subcontractors you have done business with for a long time and warrant continued patronage on the basis that it s better to deal with those subcontractors you know than those you don t. They may not even be contemplating ISO 9000 certification but you get a good product, a good service, and no hassle. 

Class C ISO 9000 certified and no demonstrated capabilify. This is the class of those certified subcontractors with which you have done no business. This may appear a contradiction, as ISO 9000 certification is obtained on the basis of demonstrated capability, but you have not established their capability to meet your requirements. 

ISO 9000 certification was supposed to reduce the amount of subcontractor assessments by customers and it has in certain sectors. However, the ISO 9000 certification, whilst focused on a specific scope of registration, is often not precise enough to give confidence to customers for specific purchases. 

ISO 9000 requires what is called a third party assessment but involves developing first and second party strategies. First party refers to the supplier company that requests ISO 9000 certification. Second party refers to the customer whose needs have been met by the first party through the use of quality management procedures achieved by ISO 9000 compliance. Third party refers to an outside reviewer who certifies that the first party has satisfied ISO 9000 procedures. 

As it turned out, in general, pharmaceutical drug manufacturers already operating under GMP did not expect a marked benefit from being officially ISO 9000 certified. As a commonsense approach to take and combine the best of ISO and GMP, however, the use of a quality management system along the structure proposed by ISO 9000 became accepted practice in the industry. Manufacturers of API, on the other hand, and producers and suppliers of bulk chemicals, found the idea of getting the ISO 9000 certification quite attractive. 

Protocol for self-auditing of analytical laboratories for ISO 9000 certification. 

The ISO 9000 standards represent an international consensus on the essential features of a quality system to ensure the effective operation of any business, whether a manufacturer or service provider or other type of organization, whether in the public or private sector. Many major diagnostic companies have received ISO 9000 certification, and in 1996, the Excel Bestview Medical Laboratories of Mississauga, Ontario, Canada became the world s first clinical laboratory to receive ISO 9002 certification. (Note that an organization apphes for certification under the section that most closely represents its structure.) Elements of ISO 9002 certification (http //www.revereelectric.com/eleISO.html)... 

ISO certification is carried out by accredited organizations known as registrars. Registrars review the organization s quality manual and audit the process to ensure that the system documented in the manual is in place and effective. When an organization receives ISO 9000 certification,... 

In ISO 9001, 9002 and 9003, measurements and quality requirements for measurements or tests are required. Therefore, analytical chemists employed in industries or services pursuing ISO 9000 certification will see their analytical activity audited and controlled. 

NAMAS accreditation is similar to the ISO 9000 certification process, in that it requires a thorough assessment by independently appointed industry experts. Six months following accreditation, a full follow-up visit is made by UKAS, and aimual audits are made thereafter. Four years after accreditation a full re-accreditation assessment is made, although UKAS can make unannounced visits at any time. Laboratories found to be unsatisfactory on inspection will lose NAMAS accreditation until such time as that laboratory again meets the required standard. 

The manufacturer has an ISO 9000 certificate or a corresponding Quality Assurance System/Quality Management System (QMS). 

ISO-9000 certification ISO-9000 and lSO-9004 are guidelines that interpret the requirements of the three main standards—ISO-9001 (the quality system in design and development), ISO-9002 (the quality system for quality assurance in production and installation), and ISO-9003 (the quality system for quality assurance in final inspection and testing). These three standards define the quality-system requirements for firms with a varying scope of business requirements. See design verification fabricating, world-class processor certification productivity quality system test certification testing and quality control transducer calibration. 

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